HomePharma & BiotechDrug Discovery and DevelopmentA Historical First against One of the Most Trickiest Diseases

A Historical First against One of the Most Trickiest Diseases

Human beings have the most fascinating abilities in their arsenal, but at the same time, none impact us more than our ability to grow on a consistent basis. This progressive approach, on our part, has already got the world to hit upon some huge milestones, with technology appearing as a major member of the group. The reason why technology enjoys such an esteemed stature among people is, by and large, predicated upon its core make-up, which ushered us towards a reality that nobody could have ever imagined otherwise. Nevertheless, if we look up close for a second, it will become clear how the whole runner was also very much inspired from the way we applied those skills across a real world environment. The latter component was, in fact, what gave the creation a spectrum-wide presence, and consequentially, kickstarted a tech revolution. Of course, this revolution then went on to scale up the human experience through some outright unique avenues, but even after achieving such a monumental feat, technology will somehow continue to produce the right goods. The same has grown increasingly evident over the recent past, and assuming one new healthcare-themed development shakes out just like we envision, it will only make that trend bigger and better moving forward.

Novartis, a global leader in immuno-dermatology and rheumatology, has officially secured US Food and Drug Administration’s (FDA) approval for its drug, Cosentyx® (secukinumab), which is meant to treat moderate to severe hidradenitis suppurativa (HS) in adults. Talk about HS, it is a chronic, systemic and often painful skin disease that causes recurring boil-like lumps. These lumps may burst into open wounds and cause irreversible scarring, often in the most intimate parts of the body. Despite its clear severity, it can take people, on an average; around 10 years to even get the correct diagnosis, a factor that unsurprisingly ends up contributing towards disease progression and making the patient’s condition significantly worse. Enter Cosentyx, only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine believed to be involved in the inflammation of HS. The stated recognition, however, only came after digging through the largest Phase III program conducted on HS till date. Dubbed SUNRISE and SUNSHINE, the trials included in the program brought identical, global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies, studies where we saw patients being given Cosentyx 300 mg either every two weeks or every four weeks. This evaluation would stretch across 16-week (VS placebo) and 52-week treatment periods, with the drug’s effects becoming visible during as early as Week Two. Boasting a sample size of a reported 1,000 patients, the studies revealed that the initial efficacy progressively increased to Week 16, and the same trajectory was observed up until all the way to week 52. To give you a deeper look into the picture, results from the US Food and Drug Administration (FDA)-requested analysis showed that a significantly higher proportion of patients achieved a Hidradenitis Suppurativa Clinical Response (HiSCR50) when treated with Cosentyx 300 mg dosed every two weeks, compared to patients given placebo. The figures translate to a roughly 44.5% VS 29.4% in the SUNSHINE trial, whereas for SUNRISE, they clocked around 38.3% VS 26.1%. Similar success was realized with patients who were randomized to a Cosentyx 300 mg dose every four weeks. Here, the figure against placebo faction stood at 41.3% VS 29.4% and 42.5% VS 26.1% in SUNSHINE and SUNRISE trials, respectively.

“For many patients, the daily impact of HS and the search for symptom relief can last years – which can come with painful, irreversible physical and emotional scarring,” said Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE trials and Professor of Dermatology at Harvard Medical School. “This approval marks an important milestone for countless patients who have been faced with limited treatment possibilities and who now have a new option.”

First launched in 2015, Cosentyx’s credentials are backed up by the fact that is has been studied for more than 14 years. You see, it has in its corner over 8 years of real-world data in adults and 5 years of long-term safety and efficacy across moderate to severe plaque psoriasis, PsA and AS. If you don’t want data, then the drug also has real and organic success to show, having cured around 1 million patients so far. Cosentyx is already approved in 100 countries. Making the drug’s case even stronger is, of course, Novartis’ stature as a proven leader of the pharmaceutical space. An example displaying the same would be how the company’s medicine line-up reaches, at the moment, more than 250 million people worldwide.

“HS is one of the most devastating and exhausting skin diseases. The pain of flares can be debilitating and limits my ability to work or participate in social activities. It can have a major impact on me physically and emotionally, including feelings of anxiety, stress and isolation,” said Donna Atherton, EdD, Founder and Chief Mission Officer at International Association of Hidradenitis Suppurativa Network (IAHSN). “The approval of a new treatment option brings fresh hope to me and the HS community that we may find relief from the burden of the disease.”

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